The US FDA often reminds advisory committees that price is not part of its mission, but the agency pointedly told the experts meeting to review Lilly/Innovent’s sintilimab that “competition” should not be a factor either. Do they really mean that?
The 10 February US Food and Drug Administration advisory committee review of Eli Lilly and Company/Innovent Biologics, Inc.’s sintilimab kicked off with an unusually lengthy set of introductory remarks by Division of Oncology Products 2 Director Harpreet Singh, intended in part to underscore the unusual nature of the meeting.
“Today’s ODAC will not follow the traditional paradigm of assessing the benefit/risk profile of a single drug,” Singh told the...
<p>Executive Summary</p> <p>A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.</p>
Cardiovascular and Renal Drugs Advisory Committee will consider whether open-label extension data from a randomized trial that failed its primary endpoint, along with a historical control comparison, are enough to support approval in the ultra-rare disease.
<p>Executive Summary<p> <p>The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add six new products, incl/ding Ixchiq, Valneva's chikungunya virus vaccine</p>
It is unclear in a revised staff manual guide whether Commissioner's National Priority Voucher program approval “recommendations” from the drug and biologic center directors will be advisory or decisional, experts told the Pink Sheet.
Revised recommendation is based on most recent data on circulating strains in US, where KP.3 is now dominant. Novavax sticks with plans targeting the JN.1 ‘parent strain.’
Pink Sheet reporter and editors discuss the US FDA’s changes to the COVID-19 vaccine indication and its revocation of the vaccine emergency use authorizations, as well as new vaccine coverage and reimbursement questions.
